Digitek Recall

The voluntary all lot recall is due to the possibility that the Digitek tablets may contain twice the approved level of active ingredient.

On April 25, 2008 the FDA issued the Nationwide Class I Recall on all lots of Digitek.

“FOR IMMEDIATE RELEASE — Morristown, NJ — April 25, 2008 — Actavis Totowa LLC, a United States manufacturing division of the international generic pharmaceutical company Actavis Group, is initiating a Class I nationwide recall of Digitek® (digoxin tablets, USP, all strengths) for oral use. The products are distributed by Mylan Pharmaceuticals Inc., under a “Bertek” label and by UDL Laboratories, Inc. under a “UDL” label.

The voluntary all lot recall is due to the possibility that tablets with double the appropriate thickness may have been commercially released. These tablets may contain twice the approved level of active ingredient than it appropriate.

Digitek® is used to treat heart failure and abnormal heart rhythms. The existence of double strength tablets poses a risk of digitalis toxicity in patients with renal failure. Digitalis toxicity can cause nausea, vomiting, dizziness, low blood pressure, cardiac instability and bradycardia. Death can also result from excessive Digitalis intake. Several reports of illnesses and injuries have been received.

Actavis manufactures the products for Mylan and the products are distributed by Mylan and UDL under the Bertek and UDL labels. Bertek and UDL are affiliates of Mylan.

Any customer inquiries related to this action should be addressed to Stericycle customer service at 1-888-276-6166 with representatives available Monday through Friday, 8 am to 5 pm EST. Additional information about the voluntary recall can also be found at Actavis’s website.

Retailers who have this product are urged to return the product to their place of purchase. If consumers have medical questions, they should contact their health care providers.

This recall is being conducted with the knowledge of the Food and Drug Administration.”

We believe that the manufacturers who are responsible for placing these toxic double dose Digitek tablets on the market should be held accountable for their actions.  We also believe that people who have suffered injuries as a result should be treated fairly and compensated for their losses.  If you or a family member have experienced problems resulting from Digitek, please contact us today for a free, no obligation consultation. There are no legal fees or expenses unless we obtain a recovery for you.  Please contact us today.  Call toll free 1-866-777-2557 or fill out our free case consultation form.  Please keep in mind that these cases are time sensitive.  If you fail to protect your legal rights, you may lose the right to make a claim in the future.